Biopsy device with selectable tissue receiving aperture orientation and site illumination

• US 20050065453A1
• Filed: 08/03/2004
• Published: 03/24/2005
• Est. Priority Date: 02/24/2003
• Status: Active Grant

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Louw, Frank R., Quick, Richard L., Lubock, Paul, Safabash, Jason H., Shabaz, Martin V.
• Granted Patent: US 8,282,573 B2
• Time in Patent Office: Days
• US Class Current: 600/564
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00473 Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/00486 Adaptors for coupling parts with incompatible geometries
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 1/77 : Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 1/92 : with liquid supply means
• CPC Class Codes: B23Q 17/2404 : Arrangements for improving direct observation of the working space, e.g. using mirrors or lamps structural combinations of lighting devices with other articles, not otherwise provided for, F21V33/00
• CPC Class Codes: F21V 33/0068 : Medical equipment

Abstract

The invention is directed to a system and device for separating and collecting a tissue specimen from a target site within a patient. The device includes a probe component with an elongated tubular section, a penetrating distal tip and a tissue receiving aperture in the distal end of the tubular section proximal to the distal tip, and a tissue cutting member which is slidably disposed within the probe member to cut a tissue specimen drawn into the interior of the device through the aperture by applying a vacuum to the inner lumen of the tissue cutting member. The device also has a driver component to which the probe component is releasably secured. The driver has a drive member for adjusting the orientation of the tubular section and thus the aperture therein and one or more drive members for moving the tissue cutting member within the tubular section to sever a tissue specimen from tissue extending into the interior of the tubular section through the aperture. The motion imparted to the tissue cutter is at least longitudinal and preferably is also oscillation and/or rotational to effectively separate a tissue specimen from tissue extending through the aperture in the tubular section.

Claims

1. A tissue biopsy system for accessing and collecting one or more tissue specimens from a target site within a patient, comprising:

a. a disposable elongated probe component comprising

i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site, a proximal extremity configured to be secured to a driver unit, and

ii. an elongated tissue cutting member which is disposed within the tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein; and

b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut tissue extending into the tubular section through the tissue receiving aperture thereof.

2. The system of claim 1 wherein the driver component has a third driver motor configured to rotate the tissue cutting member within the tubular section.

3. The system of claim 2 wherein the third driver motor rotates the tissue cutting member within the tubular section as the tissue cutting member moves longitudinally therein.

4. The system of claim 1 wherein the driver component has a third driver motor configured to oscillate the tissue cutting member within the tubular section.

5. The system of claim 4 wherein the third driver motor oscillates the tissue cutting member within the tubular section as the tissue cutting member moves longitudinally therein.

6. The system of claim 1 including a vacuum source connected in fluid communication with the inner lumen of the tissue cutting member to withdraw tissue therethrough.

7. The system of claim 6 wherein a tissue collector is in fluid communication with the inner lumen of the tissue cutting member configured to receive tissue withdrawn through the tissue cutting member.

8. The system of claim 7 wherein the tissue collector is located between the tissue cutting member and the vacuum source.

9. The system of claim 1 wherein the first driving motor is configured to rotate the tubular section in discrete steps about the longitudinal axis thereof.

10. The system of claim 9 wherein the first driving motor is configured to rotate the tubular section in increments of about 15°

to about 45°

.

11. The system of claim 9 wherein the first driving motor is configured to rotate the tubular section in increments of about 30°

.

12. The system of claim 1 wherein the distal extremity of the tubular section of the probe component has a circular transverse cross-section.

13. The system of claim 1 including a protective tube which has proximal and distal ends, which has an inner lumen extending therein, which is disposed about the tubular section.

14. The system of claim 13 wherein the protective tube has multiple longitudinally oriented lobes.

15. The system of claim 1 wherein the driver component has at least one illuminating element in a distal portion thereof.

16. The system of claim 15 wherein the at least one illuminating element is a light emitting diode.

17. The system of claim 15 wherein the driver component has two illuminating elements.

18. The system of claim 15 wherein the at least one illuminating element has a manually operable switch.

19. The system of claim 18 wherein the manually operable switch is located in the distal end of the driver component.

20. The system of claim 1 wherein at least one of the driving motors are electrically powered.

21. The system of claim 1 wherein at least one of the driving motors are hydraulically powered.

22. The system of claim 1 wherein at least one of the driving motors are pneumatically powered.

23. The system of claim 1 including a control module which has an electrical source and a vacuum source.

24. The system of claim 23 wherein the control module controls the rotation of the tubular section.

25. The biopsy system of claim 1 wherein the driver component is configured for mounting onto a stereotactic stage of a mammography system.

26. A tissue biopsy system for accessing and collecting one or more tissue specimens from a target site within a patient, comprising:

a. a disposable elongated probe component comprising

i. an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a tissue penetrating distal tip and which has an aperture proximal to the penetrating distal tip configured to receive tissue from the target site, and

ii. an elongated tissue cutting member which is disposed within the elongated tubular section, which has at least one tissue cutting edge, which has an inner lumen extending therein and which is configured to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member;

b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section, which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section of the probe to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member; and

c. at least one light source in a distal portion of the driver component for illuminating an operation site.

27. The biopsy system of claim 26 wherein the driver component is configured for mounting onto a stereotactic stage of a mammography system.

28. The biopsy system of claim 26 wherein the driver component has a third driving motor configured to rotate the tissue cutting member.

29. The biopsy system of claim 28 wherein the third driving motor is configured to rotate the tissue cutting member as the member is moved longitudinally within the tubular section.

30. The system of claim 26 wherein the at least one illuminating element is a light emitting diode.

31. The system of claim 26 wherein the driver component has two illuminating elements.

32. The system of claim 26 wherein the at least one illuminating elements has a manually operable switch.

33. The system of claim 32 wherein the manually operable switch is located in the distal end of the driver component.

34. The system of claim 26 including a vacuum source connected in fluid communication with the inner lumen of the tissue cutting member.

35. The system of claim 34 wherein a tissue collector is in fluid communication with the inner lumen of the tissue cutting member.

36. The system of claim 35 wherein the tissue collector is located between the tissue cutting member and the vacuum source.

37. A method for collecting one or more tissue specimens from a target site within a patient, comprising:

a. providing a biopsy device having;

i. a disposable elongated probe component comprising

an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a penetrating distal tip and which has an aperture proximal to the penetrating distal tip configured to receive tissue from the target site, and

an elongated tissue cutting member which is disposed within the elongated tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein; and

ii. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member;

b. advancing the probe component at least partially into or adjacent to tissue at the target site;

c. rotating the tubular section about its longitudinal axis to provide a desired aperture orientation;

d. applying a vacuum within the tubular section to draw tissue at the tissue site through the aperture of the tubular section into the interior thereof;

e. advancing the tissue cutting member longitudinally within the tubular section to cut a tissue specimen from the tissue extending into the tubular section; and

f. transporting a cut tissue specimen through the inner lumen of the tissue cutting member.

38. The method of claim 37 wherein the longitudinal motion of the tissue cutting member includes rotational or oscillation motion.

39. The method of claim 37 wherein the tubular section is rotated about its longitudinal axis in discrete rotational increments.

40. The method of claim 37 wherein the discrete rotational increments are about 15°

to about 45°

.

41. The method of claim 40 wherein the discrete rotational increments are about 90°

.

42. A tissue biopsy probe device for accessing one or more tissue specimens from a target site within a patient, comprising:

a. an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a distal tip and which has an aperture proximal to the distal tip configured to receive tissue from the target site, and

b. an elongated tissue cutting member which is slidably disposed within the elongated tubular section, which has a distal end with at least one tissue cutting edge, which has an inner lumen extending therein and which is configured for longitudinal movement within the tubular section; and

c. a proximal housing which contains a proximal portion of the elongated tissue cutting member, a driving shuttle secured to the proximal portion of the elongated tissue cutting member and a first drive member engaging the shuttle to move the elongated tissue cutting member and a second drive member secured to a proximal portion of the tubular section within the housing configured to rotate the tubular section about its longitudinal axis.

43. The tissue biopsy probe device of claim 42 wherein the first drive member has first and second interfitting tubular drive elements with the first tubular drive element having a threaded interior and with the second tubular drive element having a threaded exterior configured to engage the threaded interior of the first tubular drive element.

44. The tissue biopsy probe device of claim 43 wherein the first tubular drive element is configured to be rotated and the second tubular drive element is fixed to the tissue cutting member.

45. The tissue biopsy probe device of claim 44 wherein the second tubular drive element is fixed to the driving shuttle.

46. The tissue biopsy probe device of claim 42 wherein a marker element is secured to the tubular section adjacent the distal face of the probe housing to indicate the orientation of the aperture in the tubular section.

47. A tissue biopsy system for collecting one or more tissue specimens from a target site within a patient, comprising:

a. a disposable elongated probe component comprising

i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site, a proximal extremity configured to be secured to a driver unit, and

ii. an elongated tissue cutting member which is disposed about the tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein; and

b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally to cut tissue extending into the tubular section through the tissue receiving aperture thereof.

48. The system of claim 47 wherein the driver component has a third driver motor configured to rotate the tissue cutting member.

49. The system of claim 48 wherein the third driver motor rotates the tissue cutting member as the tissue cutting member moves longitudinally.

50. The system of claim 47 wherein the driver component has a third driver motor configured to oscillate the tissue cutting member.

51. The system of claim 48 wherein the third driver motor oscillates the tissue cutting member as the tissue cutting member moves longitudinally.

52. The system of claim 48 including a vacuum source connected in fluid communication with the inner lumen of the tubular section of the probe component to withdraw tissue therethrough.

53. A tissue biopsy system for collecting one or more tissue specimens from a target site within a patient, comprising:

a. a disposable elongated probe component comprising

i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site and a proximal extremity configured to be secured to a driver unit, and

ii. an elongated tissue cutting member which is disposed about the tubular section, which has at least one tissue cutting edge, which has an inner lumen extending therein and which has a proximal end configured to receive a distal tip of a marker delivery device with a flared guide to guide the distal tip into the proximal end of the tissue cutting member; and

b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally to cut tissue extending through the tissue receiving aperture thereof.

54. A device for delivery of one or more marker bodies through a tubular member of a biopsy device, comprising:

a. an elongated shaft having an inner lumen and a discharge opening in a distal portion of the elongated shaft;

b. at least one marker body which is disposed within the inner lumen of the elongated shaft;

c. a pusher element which is slidably disposed within the delivery device and which is configured to urge at least one marker body out the discharge opening in the distal portion of the elongated shaft; and

d. a distally flared guide member which is disposed on the elongated shaft and which is configured to guide the distal portion of the elongated shaft into a proximal end of a tubular member of a biopsy device.

55. A tissue biopsy system for collecting at least one tissue specimen from a target site within a patient and delivering at least one marker to the target site after the at least one tissue specimen has been removed from the site, comprising:

a. a disposable elongated probe component comprising

i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site, and a proximal extremity configured to be secured to a driver unit, and

ii. an elongated tubular tissue cutting member which has at least one tissue cutting edge at a distal end, which has an opening at a proximal end and which has an inner lumen extending therein to the opening in the proximal end;

b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which [has a first driver motor] is configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which [has a second driver motor] is configured to drive the tissue cutting member longitudinally to cut tissue extending into the tubular section through the tissue receiving aperture thereof; and

c. a marker delivery component for delivery of at least one marker bodies through the tubular tissue cutting member, including;

i. an elongated shaft which has an inner lumen, a discharge opening in a distal portion of the elongated shaft and an outer diameter smaller than the inner diameter of the tubular tissue cutting member of the probe component;

ii. at least one marker body which is disposed within the inner lumen of the elongated shaft;

iii. a pusher element which is slidably disposed within the delivery device and which is configured to urge at least one marker body out the discharge opening in the distal portion of the elongated shaft; and

iv. a distally flared guide member which is disposed on the elongated shaft, which has a distal diameter much greater than the outer diameter of the proximal end of the tubular tissue cutting member and which is configured to guide the distal portion of the elongated shaft into the proximal end of the tubular cutting member.

56. A method for collecting one or more tissue specimens from a target site within a patient and delivering at least one marker body to the target site, comprising:

a. providing a biopsy device having;

i. a disposable elongated probe component comprising

an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a penetrating distal tip and which has an aperture proximal to the penetrating distal tip configured to receive tissue from the target site, and

an elongated tissue cutting member which is disposed within the elongated tubular section, which has at least one tissue cutting edge, which has an inner lumen extending therein and which is disposed within the tubular tissue cutting member with the cutting edge distal to the aperture opening so as to close the opening; and

ii. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member;

b. advancing the probe component at least partially into or adjacent to tissue at the target site with the tissue receiving aperture closed by the tissue cutter;

c. rotating the tubular section of the probe component about its longitudinal axis to provide a desired orientation to the tissue receiving aperture;

d. withdrawing the tissue cutter distally to open a desired length of the tissue receiving aperture;

e. applying a vacuum within the tubular section to draw tissue at the tissue site through the tissue receiving aperture of the tubular section into the interior thereof;

f. advancing the tissue cutting member distally within the tubular section of the probe member to cut a tissue specimen from the tissue extending into the tubular section; and

g. transporting a cut tissue specimen through the inner lumen of the tissue cutting member and out a discharge opening in the proximal end thereof;

h. providing a marker delivery device for delivery of at least one marker bodies through the tubular tissue cutting member, including;

i. an elongated shaft which has an inner lumen, a discharge opening in a distal portion of the elongated shaft and an outer diameter smaller than the inner diameter of the tubular tissue cutting member of the probe component;

ii. at least one marker body which is disposed within the inner lumen of the elongated shaft;

iii. a pusher element which is slidably disposed within the delivery device and which is configured to urge at least one marker body out the discharge opening in the distal portion of the elongated shaft; and

iv. a distally flared guide member which is disposed on the elongated shaft, which has a distal diameter much greater than the outer diameter of the proximal end of the tubular tissue cutting member and which is configured to guide the distal portion of the elongated shaft into the proximal end of the tubular cutting member;

i. advancing the marker delivery device toward the proximal end of the tubular tissue cutting member of the probe component until the distal end of the flared guide surrounds the proximal end of the tubular tissue cutting member;

j. further advancing the marker delivery device so the elongated shaft thereof extends into the inner lumen of the tubular tissue cutting member and the discharge opening in the shaft of the marker delivery device is aligned with the tissue receiving aperture of the outer tubular member; and

k. pressing the pusher element of the marker delivery device to eject at least on marker body through the discharge opening in the marker delivery device, through the tissue receiving aperture and into the target site.